Reliability of atrial screw-in leads

Area of Science:

• Cardiology
• Biomedical Engineering
• Medical Device Technology

Background:

• Atrial screw-in leads are crucial for pacemaker implantation.
• Assessing the long-term performance of novel lead designs is essential for patient care.
• Carbon coating is a material modification aimed at improving lead performance and biocompatibility.

Purpose of the Study:

• To evaluate the long-term efficacy and safety of carbon coated atrial screw-in leads.
• To analyze stimulation thresholds, lead impedance, energy consumption, and sensing parameters over time.
• To identify any performance limitations or adverse events associated with this lead type.

Main Methods:

• Prospective study involving 247 patients implanted with carbon coated atrial screw-in leads.
• Measurement of initial stimulation thresholds, lead impedance, P wave amplitude, and energy consumption.
• Follow-up assessments of these parameters at a mean of 16.4 months.
• Analysis of lead performance under various programming settings, including safety programming.

Main Results:

• Excellent threshold results (76%) allowed for reduced output programming, decreasing energy consumption by 34.6%.
• 80% of patients maintained adequate P wave amplitudes for sensing, with 38% functioning at minimal sensitivity settings.
• Only 8% of leads showed unsatisfying thresholds, primarily within the first three months post-implantation. Loss of capture occurred in 2% and loss of sensing in 0.5%.

Conclusions:

• Carbon coated atrial screw-in leads demonstrate favorable long-term performance in pacemaker patients.
• The leads facilitate energy-efficient operation through stable pacing thresholds and adequate sensing.
• While minor issues like threshold increase and loss of capture/sensing were observed, they were infrequent and manageable.